Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to compare standardized nutrition therapy provided by a registered dietitian (RD) at regularly scheduled intervals to usual care in terms of the ability to improve growth parameters in medically complex infants in the pediatric outpatient setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMay 16, 2018
May 1, 2018
11 months
April 30, 2018
May 10, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
4 months corrected gestational age (CGA)
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
8 months corrected gestational age (CGA)
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
12 months corrected gestational age (CGA)
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
1 year corrected gestational age (CGA)
Secondary Outcomes (6)
Number of participants with growth failure
1 year corrected gestational age (CGA)
Number of participants who are malnourished
1 year corrected gestational age (CGA)
Severity of malnutrition as assessed by the AND/ASPEN criteria
1 year corrected gestational age (CGA)
Number of emergency department visits
1 year corrected gestational age (CGA)
Number of hospitalizations
1 year corrected gestational age (CGA)
- +1 more secondary outcomes
Study Arms (2)
Standardized Medical Nutrition Therapy
EXPERIMENTALStandardized Medical Nutrition Therapy will include nutrition assessment provided by a registered dietitian (RD) at initial clinic visit or first Well Child Check (WCC) and regularly scheduled nutrition follow-up at each WCC visit thereafter.
Usual Care
ACTIVE COMPARATORAt the primary care provider's discretion, a nutrition consult can be requested for the RD to perform nutrition assessment or discuss the patient's plan without full nutrition assessment, as is current practice. Currently in the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UTHealth, providers consult the RD as deemed appropriate with no established criteria for when to include the RD in patient care. Usual care will not be modified by the study protocol.
Interventions
Standardized Medical Nutrition Therapy will include nutrition assessment provided by a registered dietitian (RD) at initial clinic visit or first Well Child Check (WCC) and regularly scheduled nutrition follow-up at each WCC visit thereafter.
At the primary care provider's discretion, a nutrition consult can be requested for the RD to perform nutrition assessment or discuss the patient's plan without full nutrition assessment, as is current practice. Currently in the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UTHealth, providers consult the RD as deemed appropriate with no established criteria for when to include the RD in patient care. Usual care will not be modified by the study protocol.
Eligibility Criteria
You may qualify if:
- Patients who are admitted between July, 2018 and June, 2019 to the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UT Health from a neonatal intensive care unit (NICU)
You may not qualify if:
- short bowel syndrome,
- requiring parenteral nutrition (PN)
- active cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Candice R Poland, MS, RD, LD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Registered Dietitian
Study Record Dates
First Submitted
April 30, 2018
First Posted
May 11, 2018
Study Start
July 1, 2018
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
May 16, 2018
Record last verified: 2018-05